Prosthetic valve with protective sleeve around an outlet rim

ABSTRACT

An expandable prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an expandable annular valve body. The valve body may include an atrial inlet opening and a ventricular outlet opening. The valve body may additionally include a plurality of tissue anchors extending from the valve body. The prosthetic valve may additionally include a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority from U.S. Provisional PatentApplication No. 62/560,384, filed Sep. 19, 2017, which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

This disclosure relates generally to prosthetic valves and deliverysystems for prosthetic valves. More specifically, this disclosurerelates to prosthetic heart valves and methods thereof.

BACKGROUND

The native heart valves (the tricuspid valve, pulmonary valve, mitralvalve, and aortic valve) play an important role in regulating flow ofblood through the cardiovascular system. However, the native heartvalves may become damaged or impaired due to, for example,cardiovascular diseases, infections, or congenital malformations, thuslimiting the ability of the native heart valves to regulate blood flow.This deficiency may result in reduced cardiovascular function or evendeath.

To treat these conditions, prosthetic heart valves may be implanted ator near the site of a damaged or impaired native valve. A prostheticheart valve may assist or replace the functionality of an impairednative valve, leading to better regulation of blood flow and improvedcardiovascular function. However, many existing prosthetic heart valvesrequire implantation via an open heart procedure, which ishighly-invasive and may cause life-threatening complications. Otherprosthetic valves may be collapsed within a prosthetic valve deliverysystem and advanced into the heart, at which point the prosthetic valvemay be removed from the delivery system and expanded at the native valvesite. However, many of these prosthetic valves are large in size andtherefore difficult to deliver into the heart without causing damage tohealthy tissue along the implantation route. In addition, once theseprosthetic valves are situated within the heart, they may be difficultto securely implant at the native valve site due to their complexstructure and the limited maneuverability of existing prosthetic valvedelivery systems within the heart. Moreover, many prosthetic valves areso large that they may protrude several centimeters into surroundingheart chambers once they are implanted, impairing cardiac filling andcausing injury to the anatomy within the heart.

Thus, there remains a need for prosthetic heart valves that are smallerin size but that are still configured to assist or replace thefunctionality of a diseased or damaged native heart valve. In addition,there remains a need for prosthetic heart valves that are more easilymaneuvered into the heart and securely implanted at the site of a nativeheart valve. Moreover, there remains a need for improved prostheticheart valve delivery systems that are configured to securely implant aprosthetic heart valve at an implantation site. The present disclosureprovides prosthetic heart valves with a reduced axial length such thatthe prosthetic heart valves may be more easily delivered into the heartand may exhibit less protrusion into the chambers of the heart. Thepresent disclosure also provides improved prosthetic heart valvedelivery systems and methods of implanting prosthetic heart valves, suchthat prosthetic heart valves may be securely anchored at theimplantation site.

SUMMARY

The present disclosure discloses prosthetic valves for implantationwithin a native valve and methods for implanting prosthetic valveswithin a native valve. Particular examples of the disclosure may pertainto a prosthetic valve formed at least partially of a valve body and aprotective sleeve.

According to an exemplary embodiment of the present disclosure, anexpandable prosthetic valve for implantation within a native heart valveis provided. The prosthetic valve includes an expandable annular valvebody having an atrial inlet opening and a ventricular outlet opening.The valve body additionally includes a plurality of tissue anchorsextending from the valve body. The prosthetic valve additionallyincludes a flexible annular protective sleeve positioned about the rimof the valve body outlet opening and affixed to the outlet opening.

The protective sleeve is constructed of a polymer. The polymer is PTFE.Stitching is passed around the protective sleeve to secure it relativeto the rim of the valve body outlet opening. The stitching does not passthrough the protective sleeve. The stitching passes between an areawithin the valve body and an area external to the valve body. Theprosthetic sleeve wraps around the rim of the valve body outlet opening.The protective sleeve contacts a radially inner surface of the valvebody and a radially outer surface of the valve body. The protectivesleeve is configured to protect chordae tendineae from damage by theprosthetic valve. The protective sleeve is situated over a skirt layerextending about a circumference of the valve body. A thickness of theprotective sleeve is larger than a thickness of the skirt layer. Theprotective sleeve does not contact the plurality of tissue anchors. Theradial expansion and contraction of the valve body is substantiallyunimpeded by the protective sleeve. Movement of the plurality of tissueanchors between a radially-contracted configuration and aradially-expanded configuration is substantially unimpeded by theprotective sleeve. The prosthetic valve additionally includes at leastone post secured to the valve body and configured to engage a deliverytool. The at least one post extends in a ventricular direction beyondthe protective sleeve. The at least one post is situated at a radiallyinward position relative to the protective sleeve. The prosthetic valveadditionally includes a plurality of leaflets situated within the valvebody. A point of connection between the leaflets and the valve body isaligned in a common lateral plane with the protective sleeve or situatedin an atrial direction relative to the protective sleeve. The tissueanchors are configured to engage ventricular tissue of a native heartvalve. The prosthetic valve additionally includes a plurality of atrialtissue anchors configured to engage atrial tissue of the native heartvalve. The valve body includes an annular outer frame and an inner framesituated at least partially within the annular outer frame. The tissueanchors configured to engage ventricular tissue extend from the annularouter frame. The atrial tissue anchors extend from the inner frame. Theprotective sleeve contacts a radially inner surface of the inner frameand a radially outer surface of the annular outer frame.

Additional features and advantages of the disclosed embodiments will beset forth in part in the description that follows, and in part will beobvious from the description, or may be learned by practice of thedisclosed embodiments. The features and advantages of the disclosedembodiments will be realized and attained by the elements andcombinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description andthe following detailed description are examples and explanatory only andare not restrictive of the disclosed embodiments as claimed.

The accompanying drawings constitute a part of this specification. Thedrawings illustrate several embodiments of the present disclosure and,together with the description, serve to explain the principles of thedisclosed embodiments as set forth in the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a front elevation view of an exemplary frame for aprosthetic valve, consistent with various embodiments of the presentdisclosure.

FIG. 1B illustrates a perspective view of the exemplary frame of FIG.1A, consistent with various embodiments of the present disclosure.

FIG. 2A illustrates a front elevation view of another exemplary framefor a prosthetic valve, consistent with various embodiments of thepresent disclosure.

FIG. 2B illustrates a top plan view of the exemplary frame of FIG. 2A,consistent with various embodiments of the present disclosure.

FIG. 2C illustrates an enlarged view of an atrial anchoring arm and aventricular anchoring leg of the exemplary frame of FIG. 2A, consistentwith various embodiments of the present disclosure.

FIG. 2D illustrates another front elevation view of the exemplary frameof FIG. 2A, consistent with various embodiments of the presentdisclosure.

FIG. 2E illustrates another top plan view of the exemplary frame of FIG.2A, consistent with various embodiments of the present disclosure.

FIG. 3A illustrates a front elevation view of an inner frame of theexemplary frame of FIG. 2A, consistent with various embodiments of thepresent disclosure.

FIG. 3B illustrates an enlarged view of an atrial anchoring arm of theexemplary inner frame of FIG. 3A, consistent with various embodiments ofthe present disclosure.

FIG. 3C illustrates a front elevation view of an outer frame of theexemplary frame of FIG. 2A, consistent with various embodiments of thepresent disclosure.

FIG. 3D illustrates an enlarged view of a ventricular anchoring leg ofthe exemplary outer frame of FIG. 3C, consistent with variousembodiments of the present disclosure.

FIG. 4A illustrates a cross-sectional view of the exemplary frame ofFIG. 2A, consistent with various embodiments of the present disclosure.

FIG. 4B illustrates an enlarged view of a volume between an atrialanchoring arm and a ventricular anchoring leg of the exemplary frame ofFIG. 4A, consistent with various embodiments of the present disclosure.

FIGS. 5A-5E illustrate structural changes in the exemplary frame of FIG.2A during transitioning of the frame between a radially-contractedconfiguration and a radially-expanded configuration, consistent withvarious embodiments of the present disclosure.

FIG. 6A illustrates a front elevation view of an exemplary prostheticvalve, consistent with various embodiments of the present disclosure.

FIG. 6B illustrates a cross-sectional view of the exemplary prostheticvalve of FIG. 6A without leaflets, consistent with various embodimentsof the present disclosure.

FIG. 6C illustrates a cross-sectional view of the exemplary prostheticvalve of FIG. 6A with leaflets, consistent with various embodiments ofthe present disclosure.

FIG. 6D illustrates a top plan view of the exemplary prosthetic valve ofFIG. 6A with uninflated leaflets, consistent with various embodiments ofthe present disclosure.

FIG. 6E illustrates a top plan view of the exemplary prosthetic valve ofFIG. 6A with inflated leaflets, consistent with various embodiments ofthe present disclosure.

FIG. 7A illustrates an exemplary prosthetic valve delivery system,consistent with various embodiments of the present disclosure.

FIG. 7B illustrates an enlarged view of a delivery capsule of theexemplary prosthetic valve delivery system of FIG. 7A, consistent withvarious embodiments of the present disclosure.

FIG. 7C illustrates an exemplary configuration of a telescoping catheterassembly and the delivery capsule of the exemplary prosthetic valvedelivery system of FIG. 7A, consistent with various embodiments of thepresent disclosure.

FIG. 7D illustrates another exemplary configuration of the telescopingcatheter assembly and delivery capsule of FIG. 7C, consistent withvarious embodiments of the present disclosure.

FIG. 8A illustrates another enlarged view of the exemplary deliverycapsule of the prosthetic valve delivery system of FIG. 7A in a closedconfiguration, consistent with various embodiments of the presentdisclosure.

FIG. 8B illustrates the exemplary delivery capsule of FIG. 8A in an openconfiguration, consistent with various embodiments of the presentdisclosure.

FIG. 8C illustrates an interior view of the exemplary delivery capsuleof FIG. 8A in the closed configuration, consistent with variousembodiments of the present disclosure.

FIG. 9 illustrates advancement of the exemplary prosthetic valvedelivery system of FIG. 7A into the left atrium, consistent with variousembodiments of the present disclosure.

FIGS. 10A-10H depict implantation of the prosthetic valve of FIGS. 6A-6Ewithin a native mitral valve by the exemplary prosthetic valve deliverysystem of FIG. 7A, consistent with various embodiments of the presentdisclosure.

DETAILED DESCRIPTION

Exemplary embodiments are described with reference to the accompanyingdrawings. In the figures, which are not necessarily drawn to scale, theleft-most digit(s) of a reference number identifies the figure in whichthe reference number first appears. Wherever convenient, the samereference numbers are used throughout the drawings to refer to the sameor like parts. While examples and features of disclosed principles aredescribed herein, modifications, adaptations, and other implementationsare possible without departing from the spirit and scope of thedisclosed embodiments. Also, the words “comprising,” “having,”“containing,” and “including,” and other similar forms are intended tobe equivalent in meaning and be open ended in that an item or itemsfollowing any one of these words is not meant to be an exhaustivelisting of such item or items, or meant to be limited to only the listeditem or items. It should also be noted that as used in the presentdisclosure and in the appended claims, the singular forms “a,” “an,” and“the” include plural references unless the context clearly dictatesotherwise.

In some embodiments of the present disclosure, an “atrial direction” mayrefer to a direction extending towards an atrium of the heart. Forexample, from a location within the left ventricle or the mitral valve,an atrial direction may refer to a direction extending towards the leftatrium. Additionally, from a location within an atrium (e.g., the leftatrium), an atrial direction may refer to a direction extending awayfrom an adjacent atrioventricular valve (e.g., the mitral valve) andfurther into the atrium. For example, in FIGS. 10G and 10H, an atrialdirection may refer to a direction extending upwards from prostheticvalve 6000 towards atrium 9010. In some exemplary embodiments, an atrialdirection need not necessarily be parallel to a longitudinal axis of aprosthetic valve (e.g., longitudinal axis 2800 illustrated in FIG. 2A),so long as the direction is angled towards an atrium. The atrialdirection may be parallel to a longitudinal axis of a prosthetic valvein some cases. In some embodiments, a “non-ventricular direction” mayrefer to a direction that does not extend towards a ventricle of theheart. A “non-ventricular direction” may extend in an atrial direction,or it may extend laterally in a direction perpendicular to a ventriculardirection.

In some exemplary embodiments of the present disclosure, a “ventriculardirection” may refer to a direction extending towards a ventricle of theheart. From a location within the left atrium or the mitral valve, aventricular direction may refer to a direction extending towards theleft ventricle. Additionally, from a location within a ventricle (e.g.,the left ventricle), a ventricular direction may refer to a directionextending away from an adjacent atrioventricular valve (e.g., the mitralvalve) and further into the ventricle. For example, in FIGS. 10G and10H, a ventricular direction may refer to a direction extendingdownwards from prosthetic valve 6000 towards ventricle 9020. In someexemplary embodiments, a ventricular direction need not necessarily beparallel to a longitudinal axis of a prosthetic valve (e.g.,longitudinal axis 2800 illustrated in FIG. 2A), so long as the directionis angled towards a ventricle. The ventricular direction may be parallelto a longitudinal axis of a prosthetic valve in some cases. In someembodiments, a “non-atrial direction” may refer to a direction that doesnot extend towards an atrium of the heart. A non-atrial direction mayextend in a ventricular direction, or it may extend laterally in adirection perpendicular to an atrial direction.

Exemplary embodiments generally relate to prosthetic valves forimplantation within a native valve and methods for implanting prostheticvalves within a native valve. In addition, exemplary embodimentsgenerally relate to systems and methods for implantation of prostheticvalves by prosthetic valve delivery systems. While the presentdisclosure provides examples relating to prosthetic heart valves, and inparticular prosthetic mitral valves, as well as delivery systems forprosthetic heart valves, it should be noted that aspects of thedisclosure in their broadest sense are not limited to a prosthetic heartvalve. Rather, the foregoing principles may be applied to otherprosthetic valves as well. In various embodiments in accordance with thepresent disclosure, the term prosthetic valve refers generally to animplantable valve configured to restore and/or replace the functionalityof a native valve, such as a diseased or otherwise impaired native heartvalve.

An exemplary prosthetic valve may include a prosthetic valve configuredto render a native valve structure non-functional, and may thus replacethe function of the native valve. For example, an exemplary prostheticvalve may have a size and shape similar to the valve being replaced andmay include a number of leaflet-like structures to regulate fluid flowand prevent backflow of blood through the valve. Additionally, oralternatively, an exemplary prosthetic valve may also include aprosthetic valve configured to leave the native valve structure intactand functional. An exemplary prosthetic valve may include a mitralvalve, tricuspid valve, aortic valve, or pulmonary valve, as well as avalve outside of the heart, such as a venous valve, lymph node valve,ileocecal valve, or any other structure configured to control and/orregulate fluid flow in the body. An exemplary prosthetic valve mayadditionally or alternatively be configured to replace a failedbioprosthesis, such as a failed heart valve prosthesis.

FIG. 1A illustrates a front elevation view of an exemplary frame 1000for a prosthetic valve. FIG. 1B illustrates a perspective view of frame1000. Frame 1000 may be constructed of a shape memory material such asnickel titanium alloy (Nitinol) and may be configured to support othercomponents of the prosthetic valve, such as prosthetic leaflets andprotective cover layers. Frame 1000 may include an annular outer frame1200 and an inner frame 1400 situated at least partially within theouter frame 1200. Annular outer frame 1200 and inner frame 1400 may besecured together by pins, screws, welding, soldering, adhesive, magnets,and/or any other suitable mechanism. For example, FIGS. 1A and 1B depictannular outer frame 1200 and inner frame 1400 connected by a pluralityof connector pins 1040.

Annular outer frame 1200 may include an outer frame tubular portion1220, which may be formed of a plurality of struts intersecting atjunctions to form a wire mesh, stent-like, or cage-like structure of theouter frame tubular portion 1220. Annular outer frame 1200 may alsoinclude at least one ventricular anchoring leg 1240, which may beconfigured to extend radially outward from the outer frame tubularportion and which may contact, or otherwise engage, tissue within ornear the native valve to anchor the prosthetic valve within the nativevalve. In some embodiments, exemplary valve frame 1000 may includetwelve ventricular anchoring legs 1240, which may be configured toengage ventricular tissue of a native atrioventricular valve.

Inner frame 1400 may include an inner frame tubular portion 1420, whichmay be formed of a plurality of struts intersecting at junctions to forma wire mesh, stent-like, or cage-like structure of the inner frametubular portion 1420. Inner frame 1400 may also include at least oneatrial anchoring arm 1440, which may be configured to extend radiallyoutward from the inner frame tubular portion and which may contact, orotherwise engage, tissue within or near the native valve to anchor theprosthetic valve within the native valve. In some embodiments, exemplaryvalve frame 1000 may include twelve atrial anchoring arms 1440, whichmay be configured to engage atrial tissue of a native atrioventricularvalve.

Outer frame tubular portion 1220 and inner frame tubular portion 1420may together form an annular valve body 1020 of the prosthetic valve,which may have at least one opening and from which the ventricularanchoring legs 1240 and atrial anchoring arms 1440 may extend. Annularvalve body 1020 may include an axial lumen 1022 extending through theannular valve body 1020 along a longitudinal axis 1800 of the prostheticvalve. In some embodiments, annular valve body 1020 may be configured toreceive a flow control device, such as one or more prosthetic leaflets,within axial lumen 1022. Optionally, annular valve body 1020 may includeone or more atrial end delivery posts 1027 along an atrial end (i.e.,top end) of the annular valve body and/or one or more ventricular enddelivery posts 1028 along a ventricular end (i.e., bottom end) of theannular valve body. Delivery posts 1027 and 1028 may be configured toremovably engage a delivery device of the prosthetic valve, for example,to assist with placement of frame 1000 within or near a native valve.

FIG. 2A illustrates a front view of another exemplary frame 2000 for aprosthetic valve. FIG. 2B illustrates a top plan view of the frame 2000.Frame 2000 may include an annular outer frame 2200 and an inner frame2400 situated at least partially within the annular outer frame 2200.Annular outer frame 2200 and inner frame 2400 may be secured together bypins, screws, welding, soldering, adhesive, magnets, and/or any othersuitable mechanism. For example, FIGS. 2A and 2B depict annular outerframe 2200 and inner frame 2400 connected by a plurality of connectorpins 2040.

Annular outer frame 2200 may include an outer frame tubular portion3605, which may be formed of a plurality of struts intersecting atjunctions to form a wire mesh, stent-like, or cage-like structure of theouter frame tubular portion 3605. For example, as illustrated in FIG.2A, annular outer frame 2200 may include outer frame atrialcircumferential struts 3608 a, outer frame leg base struts 3608 b, andouter frame ventricular circumferential struts 3608 c intersecting atatrial end outer frame junctions 3602, leg attachment junctions 3802,outer frame junctions 3804, and ventricular end outer frame junctions3604 to form outer frame tubular portion 3605. Annular outer frame 2200may also include at least one ventricular anchoring leg 2240, which mayextend from leg attachment junction 3802 of the outer frame tubularportion 3605 and which may be configured to engage ventricular tissue ofa native valve to anchor the prosthetic valve in the native valve. Theat least one ventricular anchoring leg 2240 may include a proximal legend 3622, which may be the end of the leg connected to the outer frametubular portion, and a distal leg end 2244, which may be situatedradially outward from the outer frame tubular portion. As shown in FIG.2B, the at least one ventricular anchoring leg 2240 may include at leastone opening 2242.

Inner frame 2400 may include an inner frame tubular portion 3005, whichmay be formed of a plurality of struts intersecting at junctions to forma wire mesh, stent-like, or cage-like structure of the inner frametubular portion 3005. For example, as illustrated in FIG. 2A, innerframe 2400 may include inner frame atrial struts 3008 a, inner frameintermediate struts 3008 b, and inner frame ventricular struts 3008 cintersecting at atrial end inner frame junctions 3002, arm attachmentjunctions 3202, inner frame strut junctions 3204, and ventricular endinner frame junctions 3004 to form inner frame tubular portion 3005.Inner frame 2400 may also include at least one atrial anchoring arm2440, which may extend from arm attachment junction 3202 of the innerframe tubular portion 3005 and which may be configured to engage atrialtissue of a native valve to anchor the prosthetic valve in the nativevalve. The at least one atrial anchoring arm 2440 may include a proximalarm end 3020, which may be the end of the arm connected to the innerframe tubular portion, and a distal arm end 2444, which may be situatedradially outward from the inner frame tubular portion. As shown in FIG.2B, the at least one atrial anchoring arm 2440 may include a proximalarm opening 2441 and a distal arm opening 2442.

Outer frame tubular portion 3605 and inner frame tubular portion 3005may together form an annular valve body 2020 of the prosthetic valve,which may have at least one opening and from which the ventricularanchoring legs 2240 and atrial anchoring arms 2440 may extend. Annularvalve body 2020 may include an axial lumen 2022 extending through theannular valve body 2020 along a longitudinal axis 2800 of the prostheticvalve. Annular valve body 2020 may have an atrial end 2024, aventricular end 2025 opposite the atrial end, and an intermediateportion 2026 extending between the atrial and ventricular ends. In someembodiments, the atrial end may refer to the portion of the annularvalve body configured to be situated at a location within the atriumthat is furthest from an adjacent ventricle, when the prosthetic valveis implanted in a native valve. Similarly, the ventricular end may referto the portion of the annular valve body configured to be situated at alocation within the ventricle that is furthest from an adjacent atrium,when the prosthetic valve is implanted in a native valve. Theintermediate portion 2026 may extend between the atrial end 2024 andventricular end 2025. In some embodiments, annular valve body 2020 mayinclude one or more ventricular end delivery posts 1028 along theventricular end 2025 of the annular valve body. Axial lumen 2022 mayinclude an inlet opening 2032 at the atrial end of the annular valvebody, as well as an outlet opening 2036 at the ventricular end of theannular valve body.

FIG. 2C illustrates an enlarged view of an atrial anchoring arm 2440 anda ventricular anchoring leg 2240 of frame 2000. Ventricular anchoringleg 2240 may include an inner, atrially-facing leg surface 2248 and anouter, ventricularly-facing leg surface 2249. Atrial anchoring arm 2440may include an atrially-facing arm surface 2448 and aventricularly-facing arm surface 2449. In some embodiments, atrialanchoring arm 2440 may include an arm portion 2446 configured to bearranged in a common lateral plane with leg portion 2246 of theventricular anchoring leg 2240. That is, leg portion 2246 and armportion 2446 may be positioned at the same axial position alonglongitudinal axis 2800.

FIG. 2D illustrates another front elevation view of frame 2000. Theexemplary prosthetic valve, as well as frame 2000, may have an axialheight 2560, which may extend between terminal arm ends 2444 andventricular end 2025 of the annular valve body. Inner frame tubularportion 3005 may have an axial height 2530, which may extend betweenatrial end inner frame junctions 3002 and ventricular end inner framejunctions 3004. Annular outer frame 2200 may have an axial height 2550,which may extend between terminal leg ends 2244 and ventricular end 2025of the annular valve body. Outer frame tubular portion 3605 may have anaxial height 2570, which may extend between atrial end outer framejunctions 3602 and ventricular end outer frame junctions 3604. In someembodiments, frame 2000 may have a ventricular device protrusiondistance 2540, which may represent the distance over which theprosthetic valve protrudes into a left ventricle when the prostheticvalve is implanted in a native mitral valve. Annular valve body 2020 mayinclude a valve inlet radius 2520, which may be the radius of atrialinlet opening 2032.

FIG. 2E illustrates another top plan view of frame 2000. The atrialanchoring arms 2440 may have a length 2580, and the ventricularanchoring legs 2240 may have a length 2590. The terminal arm ends 2444may define an atrial anchoring arm circumference 2640. The terminal legends 2244 may define a ventricular anchoring leg circumference 2620,which may be concentric with atrial anchoring arm circumference 2640.Inflexible portions 3402 of the atrial anchoring arms (illustrated inFIG. 3B) may have a length 2581. Serpentine structures 3406 of theatrial anchoring arms (illustrated in FIG. 3B) may have a length 2582.

FIG. 3A illustrates a front elevation view of inner frame 2400. Theatrial end inner frame junctions 3002 and ventricular end inner framejunctions 3004 may form the atrial end and ventricular end,respectively, of inner frame 2400. Inner frame intermediate portion 3006may extend between atrial end inner frame junctions 3002 and ventricularend inner frame junctions 3004. Inner frame tubular portion 3005 mayhave a radially inner surface 3018 and a radially outer surface 3016.Inner frame atrial struts 3008 a and inner frame intermediate struts3008 b may intersect at atrial end inner frame junctions 3002, armattachment junctions 3202, and strut junctions 3204 to form a first,atrial row of closed cells 3012. Inner frame intermediate struts 3008 band inner frame ventricular struts 3008 c may intersect at armattachment junctions 3202, strut junctions 3204, and ventricular endinner frame junctions 3004 to form a second, ventricular row of closedcells 3014. At least one inner frame atrial strut 3008 a may have across-sectional area 3010. At least one atrial anchoring arm 2440 mayhave a cross-sectional area 3022.

FIG. 3B illustrates an enlarged view of an atrial anchoring arm 2440 ofinner frame 2400. Atrial anchoring arm 2440 may include a proximal armportion 3502 configured to extend in an atrial direction, intermediatearm portion 3504 configured to extend in a ventricular direction, anddistal arm portion 3506 configured to extend in an atrial direction. Armtransition portion 3508 may represent the transition betweenintermediate arm portion 3504 and distal arm portion 3506. Atrialanchoring arm 2440 may also include an inflexible portion 3402 extendingto proximal arm end 3020, as well as a serpentine structure 3406, whichmay be situated radially external to the inflexible portion 3402.Inflexible portion 3402 may have a proximal end 3402 p, a distal end3402 d, and a cross-sectional area 3402 c. Serpentine structure 3406 mayhave a cross-sectional area 3406 c. In some embodiments, atrialanchoring arm 2440 may include a terminal arm region 3408 situatedradially external to serpentine structure 3406. Distal arm opening 2442may be situated within terminal arm region 3408.

FIG. 3C illustrates a front elevation view of outer frame 2200. Theatrial end outer frame junctions 3602 and ventricular end outer framejunctions 3604 may form the atrial end and ventricular end,respectively, of annular outer frame 2200. Outer frame intermediateportion 3606 may extend between atrial end outer frame junctions 3602and ventricular end outer frame junctions 3604. Outer frame tubularportion 3605 may have a radially outer surface 3618 and a radially innersurface 3620. The outer frame atrial circumferential struts 3608 a,outer frame leg base struts 3608 b, and outer frame ventricularcircumferential struts 3608 c may intersect at the atrial end outerframe junctions 3602, leg attachment junctions 3802, outer framejunctions 3804, and ventricular end outer frame junctions 3604 to formclosed cells 3616. At least one outer frame atrial circumferential strut3608 a may have a cross-sectional area 3610 and a width 3612. At leastone outer frame leg base strut 3608 b may have a cross-sectional area3614. At least one ventricular anchoring leg may have a cross-sectionalarea 3624 and a radially outer surface width 3626.

FIG. 3D illustrates an enlarged view of a portion of a ventricularanchoring leg 2240 of annular outer frame 2200. Ventricular anchoringleg 2240 may include a first, proximal curved portion 3807 and a second,distal curved portion 3808. In some embodiments, proximal curved portion3807 may face radially outward. Additionally, or alternatively, distalcurved portion 3808 may face radially inwards.

FIG. 4A illustrates a cross-sectional view of frame 2000, and FIG. 4Billustrates an enlarged view of a portion of FIG. 4A depicting a volume4000 formed between the atrial anchoring arms 2440 and ventricularanchoring legs 2240. FIG. 4B also depicts an outer surface 4010 andinner surface 4020 of annular valve body 2020. In some embodiments,volume 4000 may be bounded by the ventricularly-facing surfaces 2449 ofatrial anchoring arms 2440, by the inner, atrially-facing surfaces 2248of ventricular anchoring legs 2240, and by the outer surface 4010 of theannular valve body 2020.

FIG. 5A illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020, atrial anchoring arms 2440, andventricular anchoring legs 2240 are arranged in a radially-contractedconfiguration. In some embodiments, the configuration illustrated inFIG. 5A may constitute a radially-contracted configuration of theprosthetic valve.

FIG. 5B illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020 and atrial anchoring arms 2440 arearranged in a radially-contracted configuration. In the configuration ofFIG. 5B, the ventricular anchoring legs 2240 may deflect radiallyoutward away from annular valve body 2020, into a radially-expandedconfiguration of the ventricular anchoring legs 2240.

FIG. 5C illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020 and ventricular anchoring legs 2240 arearranged in a radially-contracted configuration. In the configuration ofFIG. 5C, the atrial anchoring arms 2440 may deflect radially outwardaway from annular valve body 2020, into a radially-expandedconfiguration of the atrial anchoring arms 2440.

FIG. 5D illustrates a configuration of the exemplary prosthetic valve inwhich the atrial anchoring arms 2440 and ventricular anchoring legs 2240may deflect radially outward away from annular valve body 2020 intotheir respective radially-expanded configurations, while annular valvebody 2020 remains in a radially-contracted configuration. In theconfiguration of FIG. 5D, an axial distance 5004 may be formed betweenthe atrial anchoring arms 2440 and the terminal ends 2244 of theventricular anchoring legs 2240.

FIG. 5E illustrates a configuration of the exemplary prosthetic valve inwhich annular valve body 2020, atrial anchoring arms 2440, andventricular anchoring legs 2240 are arranged in a radially-expandedconfiguration. In some embodiments, the configuration illustrated inFIG. 5E may constitute a radially-expanded configuration of theprosthetic valve.

FIG. 6A illustrates a front elevation view of prosthetic valve 6000. Insome embodiments, prosthetic valve 6000 may be assembled upon frame2000. Prosthetic valve 6000 may be configured for implantation within ornear a native valve structure and may be configured to restore and/orreplace the functionality of a native valve, such as a diseased orotherwise impaired native valve. Prosthetic valve 6000 may include valveframe 2000, including annular valve body 2020, the atrial anchoring arms2440, and the ventricular anchoring legs 2240. Prosthetic valve 6000 mayalso include a skirt layer 6100 configured around an external surface ofa portion of the annular valve body. Prosthetic valve 6000 mayadditionally include a first cuff sheet 6210, which may be connected toskirt layer 6100 via stitching 6104, as well as a second cuff sheet6220, which may be connected to first cuff sheet 6210 via stitching6420. In some embodiments, the first cuff sheet 6210 and second cuffsheet 6220 by extend around the terminal ends 2444 of the atrialanchoring arms 2440. Skirt layer 6100, first cuff sheet 6210, and secondcuff sheet 6220 may be constructed of fluid-impermeable material and mayaccordingly be configured to prevent passage of blood or other fluidsthrough portions of the prosthetic valve 6000 outside of the axial lumen2022.

In some embodiments, prosthetic valve 6000 may additionally include aprotective sleeve 6102 wrapped around the rim 6800 of the ventricularoutlet opening of annular valve body 2020; protective sleeve 6102 may besecured to annular valve body 2020 by stitching 6108. Additionally, oralternatively, prosthetic valve 6000 may include at least one liner 6310extending around an external surface of the ventricular anchoring legs2240, with at least one protective layer 6330 positioned around thedistal leg ends 2244 and at least one protective covering 6320 wrappedaround the proximal leg ends 3622. In some embodiments, the at least oneprotective covering 6320 may be secured to the skirt layer 6100 viastitching 6322.

FIG. 6B illustrates a cross-sectional view of prosthetic valve 6000,without prosthetic leaflets situated within the axial lumen 2022. Asillustrated in FIG. 6B, prosthetic valve 6000 may additionally include aliner 6400 covering at least a portion of the inner surface 4020 of theannular valve body 2020. Liner 6400 may be secured to the annular valvebody 2020 via stitching 6430 and to the second cuff sheet 6220 viastitching 6410. First cuff sheet 6210, second cuff sheet 6220, and innerliner 6400 may together form an inflatable cuff 6200 having an interiorvolume 6500. In some embodiments, inflatable cuff 6200 may be secured toatrial anchoring arm 2440 via connector 6440. Blood may enter the cuff6200 through openings 6230, causing the cuff 6200 to inflate radiallyoutwards and axially in an atrial direction. In some embodiments, cuff6200 may inflate radially outwards and press against tissue of thenative valve. This engagement between the cuff and tissue of the nativevalve may form a barrier to flow of blood and other fluids around theouter circumference of the prosthetic valve 6000.

FIG. 6C illustrates a cross-sectional view of prosthetic valve 6000 withprosthetic leaflets 6602 and 6604 situated within the axial lumen 2022.In some embodiments, prosthetic valve 6000 may also include a thirdprosthetic leaflet 6606, which may not be visible in the view of FIG.6C. The leaflets 6602, 6604, and 6606 may be secured to inner liner 6400via stitching 6608 and may include a connector 6610 wrapping around theventricular end delivery posts 2028 to secure the leaflets 6602, 6604,and 6606 to the valve frame 2000.

FIG. 6D illustrates a top plan view of prosthetic valve 6000, withleaflets 6602, 6604, and 6606 arranged in an open, uninflatedconfiguration. In the open configuration, a space may be formed in themiddle of the leaflets, permitting fluid to pass through the axial lumen2022 of the prosthetic valve 6000. FIG. 6E illustrates a top plan viewof prosthetic valve 6000, with leaflets 6602, 6604, and 6606 arranged ina closed, coapted configuration. In the closed configuration, theleaflets may press together such that the opening between them isclosed. For example, the point of contact 6007 between two adjacentleaflets may extend to the center of the axial lumen; as a result, theleaflets may block fluid passage through the axial lumen 2022 of theprosthetic valve 6000.

FIG. 7A illustrates a prosthetic valve delivery system 7000. Deliverysystem 7000 may be configured to deliver an implant prosthetic valve6000 within a native valve, such as a native mitral valve. Prostheticvalve delivery system 7000 may include a control handle assembly 7100, atelescoping catheter assembly 7200, a delivery capsule 7300 configuredto retain a prosthetic valve (e.g. valve 6000), and, optionally, a stand7400.

Control handle assembly 7100 may include an outer sheath control handle7120 having a steering knob 7122 configured to steer an outer sheath7210 of the telescoping catheter assembly 7200. Control handle assembly7100 may also include a guide catheter control handle 7140 having asteering knob 7142 configured to steer a guide catheter 7220 of thetelescoping catheter assembly 7200.

Control handle assembly 7100 may also include an implant cathetercontrol handle 7160 having a steering knob 7168 configured to steer animplant catheter 8100 of the telescoping catheter assembly 7200. Implantcatheter control handle 7160 may also include a proximal capsule portionslider 7162, a distal capsule portion knob 7170, and a distal capsuleportion knob lock 7172 configured to control release of the prostheticvalve 6000 from within delivery capsule 7300. Implant catheter controlhandle 7160 may also include a slide lock 7166 configured to lock theimplant catheter control handle 7160 at a position within track 7420 ofstand 7400.

Control handle assembly 7100 may also include a cradle 7180, which maybe secured to stand 7400 via a locking mechanism that can be released byactuated of release button 7184. Cradle 7180 may include a rotation knob7182 configured to control rotation of the outer sheath 7210 and guidecatheter 7220. Cradle 7180 may also include a rotation knob 7186configured to control rotation of the implant catheter 8100. Cradle 7180may also include a knob 7188 configured to control relative axialmovement between outer sheath control handle 7120 (which may be securedto outer sheath 7210) and guide catheter control handle 7140 (which maybe secured to guide catheter 7220).

FIG. 7B illustrates an enlarged view of delivery capsule 7300 ofprosthetic valve delivery system 7000. Delivery capsule 7300 may includea proximal capsule portion 7320 and a distal capsule portion 7340 with anose cone 7360 secured to the distal capsule portion 7340. A nose conedistal tip 7365 may form the distal end of the delivery capsule 7300.The telescoping catheter assembly 7200 may include a capsule shaft 7230secured to, and configured to control movement of, the proximal capsuleportion 7320 (e.g., due to connection 8400 between the capsule shaft7230 and proximal capsule portion 7320, as illustrated in FIG. 8C).Implant catheter 8100 may extend within proximal capsule portion 7320and may have a valve anchor disc 8200 connected to the distal end of theimplant catheter 8100. A torque shaft 8300 may extend from the implantcatheter 8100 and may be connected to distal capsule portion 7340;accordingly, torque shaft 8300 may be configured to control axialmovement of the distal capsule portion 7340 relative to the implantcatheter 8100 and valve anchor disc 8200. The proximal capsule portion7320 and a distal capsule portion 7340 may be configured to retainprosthetic valve 6000, with the prosthetic valve 6000 secured againstaxial movement by valve anchor disc 8200. Control handle assembly 7100may be configured to control movement of the proximal capsule portion7320 and a distal capsule portion 7340, and thus may also controlrelease of the prosthetic valve 6000 from within the delivery capsule7300.

FIGS. 7C and 7D illustrate exemplary configurations of the telescopingcatheter assembly 7200. Outer sheath 7210 and guide catheter 7220 mayinclude respective bending portions 7215 and 7225, at which the outersheath 7210 and guide catheter 7220 may be configured to bend withintheir respective steering planes 7212 and 7222. In some embodiments,bending of the outer sheath 7210 within the first steering plane 7212may be controlled by the outer sheath steering knob 7122 of the controlhandle assembly 7100. Additionally, or alternatively, bending of theguide catheter 7220 within the second steering plane 7222 may becontrolled by the guide catheter steering knob 7142 of the controlhandle assembly 7100. In some embodiments, under control of the controlhandle assembly 7100, the outer sheath 7210, guide catheter 7220, andimplant catheter 8100 may be steered so as to correctly position thedelivery capsule 7300 within a native valve for implantation of theprosthetic valve.

FIG. 8A illustrates an enlarged view of delivery capsule 7300 in aclosed configuration, while FIG. 8B illustrates an enlarged view ofdelivery capsule 7300 in an open configuration. In the closedconfiguration of FIG. 8A, the distal capsule portion 7340 and proximalcapsule portion 7320 may be brought together to form an enclosedcompartment in which prosthetic valve 6000 may be retained. In the openconfiguration of FIG. 8B, the distal capsule portion 7340 and proximalcapsule portion 7320 may be drawn apart. In some embodiments, thedelivery capsule 7300 may be configured such that the distal capsuleportion 7340 and proximal capsule portion 7320 are moved apart from eachother, the prosthetic valve 6000 may be sequentially deployed fromwithin the delivery capsule and implanted within a native valve.

FIG. 8C illustrates an interior view of delivery capsule 7300 withprosthetic valve 6000 retained within the delivery capsule. Althoughonly the valve frame 2000 of the prosthetic valve 6000 is illustrated inFIG. 8C, one of ordinary skill will understand that the entireprosthetic valve 6000 depicted in FIGS. 6A-6E may be retained withindelivery capsule 7300 in the configuration illustrated in FIG. 8C.

In the embodiment illustrated in FIG. 8C, at least a portion of theannular valve body 2020 and ventricular anchoring legs 2240 of theprosthetic valve 6000 may be retained within the distal capsule portion.Additionally, or alternatively, at least a portion of atrial anchoringarms 2440 may be retained within proximal capsule portion 7320. In someembodiments, valve anchor disc 8200 may include a number of recesses8205 configured to receive and retain the ventricular end delivery posts2028 of the prosthetic valve 6000. For example, the valve anchor disc8200 may include at least the same number of recesses 8205 as there aredelivery posts 2028 of the prosthetic valve 6000. In some embodiments,the delivery posts 2028 may be retained within the recesses 8205 so longas the annular valve body 2020 remains in a radially-contractedconfiguration; the engagement between the valve anchor disc 8200 anddelivery posts 2028 may secure the prosthetic valve 6000 against axialmovement. Upon radial expansion of the annular valve body 2020, thedelivery posts 2028 may slide or expand out of the recesses 8205,freeing the prosthetic valve 6000 from engagement with the valve anchordisc 8200.

FIG. 9 illustrates one exemplary advancement route of the deliverycapsule 7300 to the left atrium. In the example illustrated in FIG. 9,the delivery capsule 7300 may be steered through the vena cava into theright atrium 9210 and may pierce the interatrial septum and enter theleft atrium 9010. Alternatively, the delivery capsule may be deliveredto the heart by other routes. FIG. 9 also depicts the left ventricle9020, the mitral valve 9030, the chordae tendineae 9022, the aorticvalve 9045, and the aorta 9040.

FIGS. 10A-10H depict an exemplary implantation method of prostheticvalve 6000 within a mitral valve 9030. In FIG. 10A, the delivery capsule7300 may be coaxially aligned with the mitral valve 9030. In someembodiments, the prosthetic valve 6000 may be held within the deliverycapsule 7300 while the prosthetic valve is arranged in the configurationof FIG. 5A. In FIG. 10B, the delivery capsule 7300 may be distallyadvanced into the mitral valve 9030. In FIG. 10C, the distal capsuleportion 7340 may be distally advanced relative to the rest of thedelivery capsule 7300. This may release the ventricular anchoring legs2240 from the distal capsule portion 7340, while the atrial anchoringarms 2440 and annular valve body 2020 remain constrained within thedelivery capsule. In the example shown in FIG. 10C, the ventricularanchoring legs 2240 may be released from the delivery capsule 7300within the atrium 9010. In some embodiments, the prosthetic valve 6000may assume the configuration of FIG. 5B when the ventricular anchoringlegs 2240 are released in the step depicted in FIG. 10C.

In FIG. 10D, the released ventricular anchoring legs 2240 may be passedthrough the mitral valve 9030 and into the left ventricle 9020. In FIG.10E, the released legs 2240 may be proximally retracted until theventricular anchoring legs come into contact with the ventricular tissueof the mitral valve 9030. In FIG. 10F, the proximal capsule portion 7320may be retracted proximally, thus releasing the atrial anchoring arms2440 within atrium 9010 while the annular valve body 2020 remainsradially constrained within the distal capsule portion 7340. In someembodiments, the prosthetic valve 6000 may assume the configuration ofFIG. 5D when the atrial anchoring arms 2440 are released in the step ofFIG. 10F.

In FIG. 10G, the distal capsule portion 7340 may be advanced furtheruntil the annular valve body 2020 is released from the capsule andallowed to radially expand. Radial expansion of the annular valve body2020 may allow the prosthetic valve to assume the fully-expandedconfiguration illustrated in FIG. 5E. At this stage, prosthetic valve6000 may be securely implanted within mitral valve 9030. In FIG. 10H,the delivery system 7000, including capsule 7300, may be removed.

Various embodiments of the present disclosure relate to prostheticvalves, including prosthetic heart valves. While the present disclosureprovides examples of prosthetic heart valves, and in particularprosthetic mitral valves, it should be noted that aspects of thedisclosure in their broadest sense are not limited to a prostheticmitral valve. Rather, the foregoing principles may be applied to otherprosthetic valves as well. Prosthetic heart valve 6000, illustrated inFIGS. 6A-6E, is one example of a prosthetic valve in accordance with thepresent disclosure.

In some embodiments, an exemplary prosthetic valve may be configured forimplantation within a native atrioventricular valve and may regulateblood flow between the atrium and ventricle. For example, prostheticheart valve 6000 illustrated in FIGS. 6A-6C may include afluid-impervious cuff 6200 configured to extend from an inner lumen 2022of the prosthetic valve to terminal arm ends 2444 of a plurality ofatrial anchoring arms 2440. Because cuff 6200 is constructed of afluid-impervious material, cuff 6200 may be configured to minimize orblock flow of blood and other fluids through any portion of theprosthetic valve 6000 except for lumen 2022. In addition, atrialanchoring arms 2440 of the prosthetic valve (including terminal arm ends2444) may be configured to contact and, in some embodiments, pressagainst atrial tissue of a native heart valve. This is illustrated inFIGS. 10G-10H, which depict atrial anchoring arms 2440 of prostheticvalve 6000 arranged in contact with, and exerting aventricularly-directed force (that is, a force directed downwards towardventricle 9020) upon atrial tissue of native mitral valve 9030. As aresult, cuff 6200 of prosthetic valve 6000 may also be configured tominimize or block passage of blood and other fluids between theprosthetic valve 6000 (including terminal arm ends 2444) and nativevalve tissue, a condition known as perivalvular leakage. As a result,prosthetic valve 6000 may be configured to prohibit passage of blood andother fluids between atrium 9010 and ventricle 9020, except by passagethrough inner lumen 2022, in which leaflets 6602, 6604, and 6606 may besituated.

In some embodiments, an exemplary prosthetic valve may be expandable,such as between a radially-contracted configuration (e.g., a crimpedstate) and a radially-expanded configuration. In some embodiments, theexemplary prosthetic valve may be configured to be radially contractedinto a radially-contracted configuration for introduction to theimplantation site, such as on or within a delivery device. Accordingly,in some embodiments, the radially-contracted configuration may also be adelivery configuration, in which the prosthetic valve is arranged fordelivery to the implantation site. Once at or near the implantationsite, the prosthetic valve may be radially expanded to aradially-expanded configuration, in which the prosthetic valve may beanchored at the implantation site. Accordingly, in some embodiments, theradially-expanded configuration may also be a deployed configuration, inwhich the prosthetic valve is released from the delivery tool and seatedat the implantation site.

In some embodiments, an exemplary prosthetic valve may be configured forself-expansion to the radially-expanded configuration; that is, theprosthetic valve may be biased to assume the radially-expandedconfiguration due to, at least in part, the design and/or materialcomposition of the prosthetic valve. The self-expanding prosthetic valvemay be constructed of a shape memory material such as nickel titaniumalloy (Nitinol), which may permit the prosthetic valve to expand to apre-determined diameter upon removal of a constraining force and/orapplication of heat or energy. For example, the prosthetic valve may becontracted and held in the radially-contracted configuration by aconstraining device, such as a sheath, catheter, stent, or deliverycapsule. An example of such a constraining device is illustrated inFIGS. 8A-8C, which illustrates prosthetic heart valve 6000 held in aradially-contracted configuration within delivery capsule 7300. When theprosthetic valve is positioned at or near the implantation site, theconstraining force may be removed and the prosthetic valve allowed toself-expand to the radially-expanded configuration. Additionally, oralternatively, an exemplary prosthetic valve may be configured to expanddue to application of radially expansive forces thereupon. For example,the prosthetic valve may be placed, in its radially-contractedconfiguration, upon an expansion device such as a balloon catheter. Uponpositioning at the implantation site, the expansion device may exert anoutwardly-directed force upon the prosthetic valve, causing it to expandto the fully-expanded configuration.

In some embodiments, a prosthetic valve may be configured forimplantation at a treatment site within the body, such as within oradjacent to a native heart valve structure. In some embodiments, aprosthetic valve may be configured for transcatheter delivery to theimplantation site via a variety of approaches, such as transapically,transatrially, and/or transseptally. In some embodiments, the prostheticvalve may be configured for implantation in the annulus or orifice of anative heart valve structure (e.g., a native heart valve). For example,in FIGS. 10A-10H, prosthetic valve 6000 may be delivered to and expandedwithin native mitral valve 9030 such that prosthetic valve 6000 isanchored within native mitral valve 9030. In some embodiments, theexemplary prosthetic valve may be configured to grasp tissue of thenative heart valve to more firmly anchor the prosthetic valve within thenative heart valve. For example, an exemplary prosthetic valve may beconfigured to grasp the native leaflets and/or native heart valveannulus to firmly seat the prosthetic valve within the valve annulus,thus preventing the prosthetic valve from migrating or dislodging fromwithin the native heart valve annulus.

In some embodiments, the prosthetic valve may include an annular valvebody. The exemplary annular valve body may be configured to receive orotherwise support a flow control device, such as one or more leaflets,for regulating flow of blood or other bodily fluids through theprosthetic valve. For example, the flow control device (e.g., leaflets)may be secured directly to the valve body and/or to an additionalstructure that is in turn secured to the valve body. As a result, whenthe prosthetic valve is implanted within a native heart valve, the flowcontrol device may regulate fluid passage through the native heartvalve, thus restoring and/or replacing the functionality of the nativevalve. In some embodiments, the exemplary valve body may be annular orring-shaped and may thus have at least one opening therein. In someembodiments, the at least one opening may extend longitudinally alongthe entire length of the annular valve body. For example, FIG. 2Billustrates an exemplary frame 2000 of a prosthetic heart valve. Heartvalve frame 2000 may include an annular valve body 2020 having an axiallumen 2022 extending longitudinally therethrough. The annular valve bodymay be sized and configured to be seated within the orifice of a nativeheart valve. For example, as depicted in FIG. 10H, annular valve body2020 may be situated within the orifice of mitral valve 9030,specifically between native leaflets 9032. In some embodiments, theannular valve body may be configured to have a smaller diameter, whenfully-expanded, than the diameter of the orifice of the native heartvalve. In such embodiments, the annular valve body may be anchored inthe native heart valve by anchoring structures, such as atrial anchoringarms and/or ventricular anchoring legs. Alternatively, the annular valvebody may be configured to expand to an equal or greater diameter thanthe diameter of the heart valve orifice such that the annular valve bodyis anchored within the heart valve.

The annular valve body may have a circular, oval-shaped, elliptical, orD-shaped cross-section and may be symmetrical about at least one axisthereof. Alternatively, the annular valve body may have any suitablecross-sectional shape with at least one opening therein. In someembodiments, at least a portion of the annular valve body may becylindrical, with a substantially constant diameter along the entirelength thereof. Alternatively, the annular valve body may have avariable diameter at different portions thereof (e.g., at differentlongitudinal portions thereof). Advantageously, such a configuration mayimprove the seating of the annular valve body within the heart valveorifice, providing an improved pressure fit therebetween.

In some embodiments, the annular valve body may be expandable, such asbetween a radially-contracted configuration (e.g., a crimped state) anda radially-expanded configuration. For example, FIGS. 5A-5D illustratean exemplary annular valve body 2020 in a radially-contractedconfiguration, while FIG. 5E illustrates annular valve body 2020 in aradially-expanded configuration. The diameter of the annular valve bodymay be reduced when the annular valve body assumes theradially-contracted configuration; for example, the annular valve bodymay be arranged in the radially-contracted configuration when theexemplary prosthetic valve is delivered to the implantation site.Conversely, the diameter of the annular valve body may be increased whenthe annular valve body assumes the radially-expanded configuration. Forexample, the annular valve body may expand to its largest possiblediameter when it is in the radially-expanded configuration.

In some embodiments, the annular valve body may be configured forself-expansion to the radially-expanded configuration; that is, theannular valve body may be biased to assume the radially-expandedconfiguration due to, at least in part, the design and/or materialcomposition of the annular valve body. The self-expanding valve body maybe constructed of a shape memory material such as nickel titanium alloy(Nitinol), which may permit the annular valve body to expand to apre-determined diameter upon removal of a constraining force and/orapplication of heat or energy. For example, the annular valve body maybe contracted and held in the radially-contracted configuration by aconstraining device, such as a sheath, catheter, stent, or deliverycapsule. An example of such a constraining device is illustrated in FIG.8C, which illustrates an exemplary prosthetic heart valve 6000 held in aradially-contracted configuration within a delivery capsule 7300. Whenthe annular valve body is positioned at or near the implantation site(e.g., at the native mitral valve 9030), the constraining force (e.g.,as applied by delivery capsule 7300) may be removed and the annularvalve body allowed to self-expand to the radially-expandedconfiguration. Additionally, or alternatively, exemplary valve bodiesmay be configured to expand due to application of radially expansiveforces thereupon. For example, the annular valve body may be placed, inits radially-contracted configuration, upon an expansion device such asa balloon catheter. Upon positioning at the implantation site, theexpansion device may exert an outwardly-directed force upon the annularvalve body, causing it to expand to the fully-expanded configuration.

In some embodiments, the exemplary valve body may be configured toradially expand independently of other components of the expandableprosthetic valve. As a result, the exemplary valve body may beconfigured to remain in a radially-contracted configuration while othercomponents of the expandable prosthetic valve, such as one or moreanchoring features, are deployed radially outward. For example, FIGS.5B-5D depict valve body 2020 remaining in a radially-contractedconfiguration while atrial anchoring arms 2440 and ventricular anchoringlegs 2240 are deployed radially outward (e.g., due to removal of aconstraining delivery device from the arms and legs).

In some embodiments, the annular valve body may include an atrial inletopening. The atrial inlet opening may be an opening or aperture at theatrial end of the axial lumen of the annular valve body; that is, theopening of the axial lumen which is configured to be situated at alocation within the atrium that is furthest from an adjacent ventriclewhen the prosthetic valve is implanted within the native heart valve.For example, in FIG. 2A, annular valve body 2020 includes an atrialinlet opening 2032, which may be an opening at the atrial end of lumen2022. In some embodiments, the atrial inlet opening may be configured asan opening or aperture through which blood or other fluid within theatrium may enter the axial lumen of the prosthetic valve. The blood orother fluid may flow along the axial lumen and exit into the ventricle.The prosthetic valve may include a flow control device, such asleaflets, within the axial lumen which may function as a one way valve.For example, the flow control device (e.g., leaflets) may permit bloodflow in one direction (e.g., from the atrium to the ventricle) but mayprevent blood flow in a second, opposite direction (e.g., from theventricle to the atrium).

In some embodiments, the annular valve body may also include aventricular outlet opening. The ventricular outlet opening may be anopening or aperture at the ventricular end of the axial lumen of theannular valve body; that is, the opening of the axial lumen which isconfigured to be situated at a location within the ventricle that isfurthest from an adjacent atrium when the prosthetic valve is implantedwithin the native heart valve. For example, in FIG. 2A, annular valvebody 2020 includes a ventricular outlet opening 2036, which may be anopening at the ventricular end of the axial lumen 2022. In someembodiments, the ventricular outlet opening may be configured as anopening or aperture through which blood or other fluid passing throughthe prosthetic valve (e.g., flowing along the axial lumen) may exit theprosthetic valve into the ventricle.

In some embodiments, the exemplary prosthetic valve may include aplurality of tissue anchors. The tissue anchors may be configured toanchor the prosthetic valve at an implantation site, such as within ornear a native heart valve. In some embodiments, the tissue anchors maybe configured to engage tissue of the native heart valve, such as atrialtissue and/or ventricular tissue, to anchor the prosthetic valve withinthe native heart valve. In some embodiments, the tissue anchors may beconfigured to be positioned at least partially within a ventricle uponimplantation of the prosthetic valve, and to engage ventricular tissueof a native mitral valve. For example, FIGS. 10E-10H depict ventricularanchoring legs 2240 of an exemplary prosthetic heart valve 6000.Ventricular anchoring legs 2240 are situated within ventricle 9020 andmay engage the ventricular side of native mitral valve 9030 to secureprosthetic heart valve 6000 within the mitral valve; accordingly,ventricular anchoring legs 2240 may be considered tissue anchors in someembodiments. Additionally, or alternatively, the annular valve body mayinclude tissue anchors configured to be positioned at least partiallywithin an atrium upon implantation of the prosthetic valve, and toengage atrial tissue of a native mitral valve. For example, atrialanchoring arms 2440 depicted in FIGS. 10F-10H are situated within atrium9010 and may engage the atrial side of native mitral valve 9030 tosecure prosthetic heart valve 6000 within the mitral valve. Accordingly,atrial anchoring arms 2440 may additionally or alternatively beconsidered tissue anchors in some embodiments.

In some embodiments, the tissue anchors may be configured to minimize orprevent migration of the prosthetic valve into a surrounding heartchamber after the prosthetic valve is implanted. This may be due, atleast in part, to the engagement of the tissue anchors with nativetissue (e.g., the ventricular side of a native heart valve) and theinability of the tissue anchors to pass through the heart valve orificeafter the prosthetic valve is implanted. For example, the tissue anchorsmay have sufficient length such that they may be configured to have agreater radius than the native heart valve. Additionally, oralternatively, the tissue anchors may be configured to grasp or clamptissue of the native heart valve to further anchor the prosthetic valvein place. For example, in the embodiment of FIGS. 10G and 10H,ventricular anchoring legs 2240 may clamp tissue by exerting anatrially-directed force (that is, a force directed towards atrium 9010)on the tissue. Additionally, or alternatively, atrial anchoring arms2440 may clamp the tissue by exerting a ventricularly-directed force(that is, a force directed towards ventricle 9020) on the tissue. Theseopposing forces may clamp or “sandwich” the native heart tissue betweenthe arms and legs, thus firmly anchoring prosthetic heart valve 6000within the native heart valve.

The prosthetic valve may include two tissue anchors, three tissueanchors, four tissue anchors, five tissue anchors, six tissue anchors,seven tissue anchors, eight tissue anchors, nine tissue anchors, tentissue anchors, eleven tissue anchors, twelve tissue anchors, thirteentissue anchors, fourteen tissue anchors, fifteen tissue anchors, sixteentissue anchors, seventeen tissue anchors, eighteen tissue anchors,nineteen tissue anchors, twenty tissue anchors, or any other suitablenumber of tissue anchors. For example, exemplary prosthetic valve 6000depicted in FIG. 2B may include twelve ventricular anchoring legs 2240(i.e., exemplary tissue anchors).

In some embodiments, the plurality of tissue anchors may be configuredto extend from the annular valve body. For example, in FIG. 2A,ventricular anchoring legs 2240 (i.e., the exemplary tissue anchors)extend from leg attachment junctions 3802 of annular valve body 2020. Insome embodiments, the tissue anchors may be physically connected to theannular valve body, such as by welding or adhesive. In some alternativeembodiments, the tissue anchors may be integrally formed with theannular valve body. In some embodiments, at least one tissue anchor mayextend from a single portion of the annular valve body. For example, inFIG. 2A, each ventricular anchoring leg 2240 may extend from a singleleg attachment junction 3802, with no two legs extending from the sameleg attachment junction. Alternatively, at least one tissue anchor mayextend from multiple points of the annular valve body.

In some embodiments, the locations of connection between the tissueanchors and annular valve body may be spaced at a regular interval abouta circumference of the annular valve body. For example, in FIG. 2A, theventricular anchoring legs 2240 (i.e., the exemplary tissue anchors) mayextend from the annular valve body 2020 at leg attachment junctions3802. Leg attachment junctions 3802 may be spaced at a regular intervalabout the circumference of annular valve body 2020. Additionally, oralternatively, the locations of connection between the tissue anchorsand annular valve body may be arranged along a plane perpendicular tothe longitudinal axis of the prosthetic valve. For example, in FIG. 2A,the leg attachment junctions 3802 may be arranged along a planeperpendicular to longitudinal axis 2800. That is, the leg attachmentjunctions 3802 may be situated at the same axial position alonglongitudinal axis 2800.

In some embodiments, the prosthetic valve may include an annularprotective sleeve positioned about the rim of the ventricular outletopening of the valve body. A sleeve may refer to a covering that fitsover or encloses a part of the prosthetic valve. The protective sleevemay be positioned about the outlet opening rim; that is, the sleeve maycover the portion of the annular valve body surrounding and forming theventricular outlet opening. For example, in FIGS. 6A-6C, protectivesleeve 6102 is positioned about rim 6800 of ventricular outlet opening2036 of the annular valve body 2020. Protective sleeve 6102 may extendaround the entirety of the outlet opening rim 6800. For example, annularvalve body 2020 may include one or more ventricular end delivery posts2028. In some embodiments, protective sleeve 6102 may extend radiallyinside or radially outside from delivery posts 2028, such thatprotective sleeve 6102 may continue uninterrupted along the entirecircumference of the outlet opening rim 6800.

In some embodiments, the protective sleeve may be annular orring-shaped, so as to accommodate the circular shape of the ventricularoutlet opening. In some embodiments, the protective sleeve may becylindrical, with a substantially constant diameter along the entireaxial length thereof. Alternatively, the protective sleeve may have avariable diameter at different portions thereof (e.g., at differentlongitudinal portions thereof). In some embodiments, the protectivesleeve may be flexible, which may be due at least in part to thematerial construction of the protective sleeve.

In some embodiments, the protective sleeve may be at least partiallyconstructed of a polymer. For example, the entirety of the protectivesleeve may be constructed a polymer. In some embodiments, a polymer mayrefer to a large molecule, or macromolecule, composed of many repeatingsubunits. In some exemplary embodiments, the polymer may be synthetic.In some alternative embodiments, the polymer may be natural. In someembodiments, the protective sleeve may be constructed of multiplepolymers.

In some embodiments, the protective sleeve may be constructed at leastpartially of polytetrafluoroethylene (PTFE), known also as “Teflon.” Forexample, the protective sleeve may be constructed entirely of PTFE.Advantageously, construction of the protective sleeve of PTFE may renderthe sleeve flexible. In some alternative embodiments, the protectivesleeve may be constructed at least partially of a thermoplastic polymer,such as polyethylene terephthalate (PET), a polycarbonate, apolyoxymethylene, an acrylic, a nylon, a polyethylene, a polypropylene,a polystyrene, a polyvinyl chloride, or a fluoropolymer. Alternatively,in some embodiments, the protective sleeve may be constructed at leastpartially of bovine pericardium.

In some embodiments, the protective sleeve may be secured relative tothe rim of the valve body outlet opening, at least in part, bystitching. In some embodiments, an additional securing mechanism, suchas an adhesive, staples, rivets, or other suitable fasteners, may beused in combination with the stitching to secure the protective sleeverelative to the outlet opening rim. In some embodiments, the protectivesleeve may be secured directly to the outlet opening rim; that is, theprotective sleeve may contact the outlet opening rim and may be securedthereto by stitching. In some alternative embodiments, portions of theprotective fabric coverings may be stitched to an intermediatestructure, such as a protective liner, which may in turn be secured tothe annular valve body. The stitching may be passed around theprotective sleeve to secure the protective sleeve relative to the rim ofthe valve body outlet opening. For example, the stitching may wraparound the protective sleeve and the outlet opening rim, following ahelical pattern along the circumference of the outlet opening rim.Alternatively, the stitching may pass around the protective sleeve inany other suitable pattern to secure it relative to the rim of the valvebody outlet opening. For example, FIGS. 6A-6C illustrate helicalstitching 6108 passing around protective sleeve 6102 to secure it tooutlet opening rim 6800. In some embodiments, the stitching does notpass through the protective sleeve to secure it to the outlet openingrim; that is, the stitching wraps around the protective sleeve ratherthan passing through a portion of the protective sleeve. In someembodiments, the stitching may pass through the protective sleeve tosecure it to the rim of the outlet opening.

In some embodiments, the stitching configured to secure the protectivesleeve to the rim of the valve body outlet opening may pass between anarea within the annular valve body and an area external to the annularvalve body. For example, the stitching may pass between the inner lumenof the annular valve body and an area external to the radially outersurface of the annular valve body. For example, FIG. 6A illustrates thearrangement of stitching 6108 in a position radially outwards from theradially outer surface 4010 of annular valve body 2020. In addition,FIG. 6B illustrates the arrangement of stitching 6108 within theinterior lumen 2022 of annular valve body 2020, in a position radiallyinward from the radially inner surface 4020 of the annular valve body.In some embodiments, stitching 6108 may extend through at least oneopening in skirt layer 6100 to pass between the areas internal to andexternal to the annular valve body 2020. Additionally, or alternatively,stitching 6108 may extend through a gap formed between protective sleeve6102 and skirt layer 6100. In some embodiments, due to the fact that thestitching wraps around the protective sleeve, which may in turn coverthe outlet opening rim, portions of the stitching may be positioned in aventricular direction from the ventricular end of the annular valvebody. That is, portions of the stitching may be configured to extendfurther into the ventricle than the ventricular end of the annular valvebody.

In some embodiments, the protective sleeve may be configured to wraparound the rim of the valve body outlet opening. That is, the protectivesleeve may wrap around the outlet opening rim between the radially outersurface of the annular valve body and the radially inner surface of theannular valve body (i.e., the surface forming the inner lumen). Forexample, in FIG. 6B, protective sleeve 6102 wraps around outlet openingrim 6800 between the radially outer surface 4010 of annular valve body2020 and the radially inner surface 4020 of annular valve body 2020. Asa result, the protective sleeve may also cover the ventricular-most endof the annular valve body (that is, the very bottom of annular valvebody 2020 in FIG. 6B).

In some embodiments, the protective sleeve may touch, or contact, one orboth of a radially inner surface of the annular valve body and aradially outer surface of the annular valve body. In some embodiments,this may be due to the wrapping arrangement of the protective sleevearound the rim of the valve body outlet opening. For example, in FIG.6B, protective sleeve 6102 contacts the inner surface 4020 and outersurface 4010 of annular valve body 2020.

In some embodiments, the protective sleeve may be configured to protectnative tissue from being injured by the prosthetic valve, and inparticular, by the ventricular outlet opening. For example, asillustrated in FIG. 10H, annular valve body 2020 may extend a shortdistance into ventricle 9020 after implantation of the prosthetic valve6000, thus creating a risk of injury to ventricular anatomy such as thechordae tendineae 9022 illustrated in FIG. 9. For example, in someembodiments the prosthetic valve may be configured to protrude adistance of between 12 millimeters and 20 millimeters into the leftventricle. For example, and without limitation, in some embodiments theprosthetic valve may be configured to protrude a distance of between16.3 and 16.5 millimeters into the left ventricle; for example, andwithout limitation, the prosthetic valve may be configured to protrude adistance of 16.4 millimeters into the left ventricle. In somealternative embodiments, the prosthetic valve may be configured toprotrude a distance of between 14.6 and 14.8 millimeters into the leftventricle; for example, and without limitation, the prosthetic valve maybe configured to protrude a distance of 14.7 millimeters into the leftventricle. Risk of injury may be due, in part, to the fact that annularvalve body may be constructed of a rigid material (e.g., Nitinol) andmay include pointed features along the outlet opening rim (e.g.,ventricular end inner frame junctions 3004 illustrated in FIG. 2A). Dueto the fact that the outlet opening rim (and any pointed featurestherein) is covered by the flexible protective sleeve, the chordaetendineae and other ventricular anatomy may be protected from injurycaused by contact with the outlet opening rim.

In some embodiments, the prosthetic valve may include a skirt layerconfigured to extend about a circumference of the annular valve body.The skirt layer may cover the outer surface of at least a portion of theannular valve body; additionally, or alternatively, the skirt layer maycover the interior surface of at least a portion of the annular valvebody. For example, prosthetic valve 6000 illustrated in FIGS. 6A-6Cincludes a skirt layer 6100 extending around a circumference (inparticular, along the outer surface 4010) of the annular valve body2020. The skirt layer may be blood-impermeable such that it may beconfigured to prevent blood leakage between the inner and outer surfacesof the annular valve body, instead directing blood through a flowcontrol device, such as one or more leaflets, situated within theannular valve body. FIGS. 6D and 6E, for example, illustrate prostheticleaflets 6602, 6604, 6606 situated within exemplary annular valve body2020.

The skirt layer may be connected to the annular valve body, for example,by stitching, adhesive, staples, rivets, and/or any suitable fasteners.In some embodiments, the skirt layer may be at least partiallyconstructed of a fabric that is impermeable to blood but which may beconfigured to allow for tissue ingrowth. For example, the skirt layermay be constructed of at least one synthetic material, such as polyestermaterial or a biocompatible polymer. Examples of a polyester materialmay include polyethylene terephthalate (PET) and expandedpolytetrafluoroethylene (ePTFE), either alone, or in combination with atleast one additional material. In some alternative embodiments, theskirt layer may be at least partially constructed of a biologicalmaterial, such as pericardial tissue (e.g., bovine, porcine, or equinepericardium) or other biological tissue.

In some embodiments, the skirt layer may contact and cover the radiallyouter surface of the valve body outlet opening. For example, FIG. 6Billustrates the arrangement of skirt layer 6100 around the radiallyouter surface of outlet opening rim 6800. In such embodiments, theprotective cover may be situated over, and may thus cover, the portionof the skirt layer situated around the outlet opening rim. For example,FIG. 6B illustrates that around outlet opening rim 6108, protectivecovering 6102 may be situated over the skirt layer 6100, along the outersurface of the annular valve body. In some embodiments, the thickness ofthe protective sleeve may be larger than the thickness of the skirtlayer. For example, in some embodiments the thickness of the protectivesleeve may be at least twice as large as the thickness of the skirtlayer. Advantageously, the thickness of the protective sleeve maycontribute to the ability of the protective sleeve to prevent injury tonative heart tissue, since the thickness may prevent features of theannular valve body from puncturing or projecting through the protectivesleeve and injuring the native anatomy. In some alternative embodiments,the thickness of the protective sleeve may be smaller than the thicknessof the skirt layer. In some further alternative embodiments, thethickness of the protective sleeve may be equal to the thickness of theskirt layer.

In some embodiments, the protective sleeve may be configured so as tonot touch or contact at least one of the tissue anchors. For example,the protective sleeve may not touch or contact any of the tissueanchors. In some embodiments, the protective sleeve may not contact thetissue anchors when the tissue anchors are in the radially-contractedconfiguration. Additionally, or alternatively, the protective sleeve maynot contact the tissue anchors when the tissue anchors are in theradially-expanded configuration. For example, FIG. 6A illustrates anembodiment in which ventricular anchoring legs 2240 (i.e., exemplarytissue anchors) are in a radially-expanded configuration. In the exampleof FIG. 6A, protective sleeve 6102 may be situated in a ventriculardirection from the entire length of each ventricular anchoring leg 2240.As a result, protective sleeve 6102 does not contact any of theventricular anchoring legs 2240. Similarly, in the example of FIG. 6A,protective sleeve 6102 may be situated in a ventricular direction fromthe entire length of each atrial anchoring arm 2440, such that theprotective sleeve 6102 does not contact any of the atrial anchoring arms2240.

In some embodiments, radial expansion and radial contraction of theannular valve body may be substantially unimpeded by the protectivesleeve. That is, the protective sleeve may be configured so as not toobstruct or hinder movement of the annular valve body between theradially-contracted configuration and the radially-expandedconfiguration. For example, portions of the protective sleeve may beconfigured to fold together when the annular valve body is in theradially-contracted configuration, such that the diameter of theprotective sleeve may be reduced to accommodate the reduced diameter ofthe annular valve body. Upon expansion of the annular valve body, theprotective sleeve may unfold to assume an annular shape with a diametersubstantially equal to the diameter of the outlet opening rim.Additionally, or alternatively, the protective sleeve may besufficiently pliant so as to accommodate structural changes in theannular valve body during radial expansion and contraction thereof.

In some embodiments, movement of the tissue anchors between aradially-contracted configuration and a radially-expanded configurationmay be substantially unimpeded by the protective sleeve. That is, theprotective sleeve may be configured so as not to obstruct or hindermovement of the tissue anchors between their respectiveradially-contracted configuration and the radially-expandedconfiguration. This may be due, at least in part, to the fact that theprotective sleeve does not touch or contact any portion of the tissueanchors, nor is the protective sleeve situated in an area through whichthe tissue anchors move when transitioning between theradially-contracted and radially-expanded configurations. For example,as illustrated in FIGS. 6A and 6B, the protective sleeve may be situatedabout the ventricular end 2025 of the annular valve body 2020. However,as FIGS. 5A-5E illustrate, neither the ventricular anchoring legs 2240nor the atrial anchoring arms 2440 move through, or otherwise come incontact with, ventricular end 2025 when transitioning between theradially-contracted and radially-expanded configurations. As a result,the protective sleeve may be configured so as to not physically block orobstruct the movement of the tissue anchors.

In some embodiments, the exemplary prosthetic valve may include at leastone delivery post secured to the valve body and configured to engage adelivery tool. The prosthetic valve may include one delivery post, twodelivery posts, three delivery posts, four delivery posts, five deliveryposts, or any other suitable number of delivery posts. The at least onedelivery post may be physically connected to the annular valve body, forinstance, by welding. Alternatively, the at least one delivery post andthe annular valve body may be manufactured as a single unitarystructure. The at least one delivery post may be constructed of the samematerial as the annular valve body and may extend in a ventriculardirection from the ventricular end of the annular valve body. Forexample, the exemplary prosthetic valve illustrated in FIGS. 5A-5E mayinclude three delivery posts 2028 extending in a ventricular directionfrom the ventricular end 2025 of the annular valve body 2020. The atleast one delivery post may be configured to engage a delivery tool ofthe prosthetic valve, for example, to secure the prosthetic valveagainst movement relative to the delivery tool. For example, in FIG. 8C,delivery posts 2028 are retained within recesses 8205 of an anchor disc8200 of the exemplary delivery capsule 7300. Due to this engagement,prosthetic valve 6000 may be prevented from longitudinal movementrelative to anchor disc 8200 until annular valve body 2020 radiallyexpands, lifting delivery posts 2028 out of engagement with recesses8205 and freeing prosthetic valve 6000 from engagement with anchor disc8200.

In some embodiments, the at least one delivery post may be configured toextend in a ventricular direction beyond the exemplary protectivesleeve. For example, the protective sleeve may be configured to extendaround the outlet opening rim in such a manner that the protectivesleeve passes around the at least one delivery post. In someembodiments, the protective sleeve may extend radially inside from theat least one delivery post, such that the at least one delivery post issituated at a radially outer position relative to the protective sleeve.In some alternative embodiments, the protective sleeve may extendradially outside of the at least one delivery post, such that the atleast one delivery post is situated at a radially inward positionrelative to the protective sleeve. For example, FIG. 6B illustratesprotective sleeve 6102 passing radially outside of the delivery posts2028, such that the delivery posts 2028 are situated at a radiallyinward position relative to the protective sleeve 6102. In someembodiments, the at least one delivery post may extend from the annularvalve body in a ventricular direction to a location beyond theprotective sleeve. For example, FIG. 6B depicts delivery post 2028extending in a ventricular direction (i.e., downward in FIG. 6B) beyondthe ventricular end of the protective sleeve 6102 (i.e., the bottomsurface of the sleeve 6102 in FIG. 6B). As a result, the at least onedelivery post may be configured to engage a delivery tool without the atleast one delivery post being covered or obstructed by the protectivesleeve.

In some embodiments, the exemplary prosthetic valve may include aplurality of leaflets situated within the annular valve body. FIG. 6D,for example, illustrates prosthetic leaflets 6602, 6604, 6606 situatedwithin the interior lumen 2022 of annular valve body 2020. Theprosthetic valve may include two leaflets, three leaflets, fourleaflets, or any other suitable number of leaflets. The leaflets may beconstructed of various suitable materials, such as natural tissue (e.g.,bovine pericardial tissue) or synthetic materials. The leaflets may beconfigured to function in a manner similar to the leaflets of the nativemitral valve. For example, the leaflets may be configured to assume anopen position (e.g., FIG. 6D), in which a space is formed between theleaflets, allowing blood and other fluids to pass between the leaflets.For example, when the leaflets are in the open position, they may beconfigured to permit blood passage from the atrium, through theprosthetic valve (in particular, through the lumen of the prostheticvalve), and into the ventricle. The leaflets may also be configured toassume a closed position (e.g., FIG. 6E), in which the leaflets maycoapt with one another so as to prevent fluid passage between theleaflets. The leaflets may function as a one way valve, such that flowin one direction (e.g., from the atrium to the ventricle) opens thevalve and flow in a second, opposite direction (e.g., from the ventricleto the atrium) closes the valve. In some embodiments, the leaflets maybe configured to open during diastole and close during systole.

In some embodiments, the leaflets may be connected to certain portionsof the annular valve body. For example, the atrial ends of the leafletsmay be connected to the annular valve body or to an intermediatestructure (e.g., a liner) which may, in turn, be connected to theannular valve body. The leaflets may be connected to the annular valvebody and/or to the intermediate structure by stitching, adhesive,staples, rivets, and/or any suitable fasteners. For example, in FIGS. 6Dand 6E, leaflets 6602, 6604, and 6606 are connected, along theirrespective atrial ends, to inner liner 6400, which may be situated atleast in part within the central lumen of annular valve body 2020.Leaflets 6602, 6604, and 6606 may be connected to inner liner 6400 viastitching 6608 and/or by any suitable fastening means. Inner liner 6400may, in turn, be connected to the annular valve body 2020, thus securingthe leaflets to the annular valve body. Additionally, or alternatively,the ventricular ends of the leaflets may be connected to the annularvalve body or to an intermediate structure (e.g., a liner) which may, inturn, be connected to the annular valve body. For example, asillustrated in FIG. 6C, leaflets 6602, 6604 (as well as leaflet 6606,which is not depicted in FIG. 6C) may be connected to one or moreventricular end delivery posts 2028, such as by stitching 6610 that mayloop around the one or more delivery posts 2028 to secure the leafletsto delivery post 2028.

In some embodiments, a point of connection between the leaflets and theannular valve body (e.g., the stitching 6610 securing leaflets 6602,6604, 6606 to delivery post 2028) may be aligned in a common lateralplane with the protective sleeve 6102. That is, the protective sleeveand the point of connection between the leaflets and the at least onedelivery post may be arranged at the same axial position relative to alongitudinal axis of the prosthetic valve. As a result, the protectivesleeve and the point of connection may be configured at a common axialposition along the longitudinal axis of the prosthetic valve. Forexample, in embodiments in which the at least one delivery post issituated at a radially inward position relative to the protectivesleeve, the point of connection between the leaflets and the deliverypost may also be situated at a radially inward position relative to theprotective sleeve. In some alternative embodiments, a point ofconnection between the leaflets and the annular valve body (e.g., thestitching 6610 securing leaflets 6602, 6604, 6606 to delivery post 2028)may be situated in an atrial direction relative to the protective sleeve6102. In further alternative embodiments, a point of connection betweenthe leaflets and the annular valve body (e.g., the stitching 6610securing leaflets 6602, 6604, 6606 to delivery post 2028) may besituated in a ventricular direction relative to the protective sleeve6102.

In some embodiments, the exemplary tissue anchors of the prostheticvalve may be configured to engage ventricular tissue of a native heartvalve, so as to anchor the prosthetic valve within the native heartvalve. For example, the tissue anchors may be configured to contact theventricular surface of the native heart valve, so as to preventmigration of the prosthetic valve in an atrial direction. Additionally,or alternatively, the tissue anchors may be configured to grasp or clamptissue of the native heart valve to further anchor the prosthetic valvein place. For example, FIGS. 10E-10H depict ventricular anchoring legs2240 (i.e., exemplary tissue anchors) situated within ventricle 9020.Ventricular anchoring legs 2240 may engage the ventricular side ofnative mitral valve 9030 to secure prosthetic heart valve 6000 withinthe mitral valve.

In some embodiments, the exemplary prosthetic valve may additionallyinclude a plurality of atrial tissue anchors. In some embodiments, theatrial tissue anchors may be configured to engage atrial tissue of thenative heart valve to anchor the prosthetic valve therein. In someembodiments, the atrial tissue anchors may be configured to bepositioned at least partially within an atrium upon implantation of theprosthetic valve, and to engage atrial tissue of the native heart valve(e.g., a native mitral valve). For example, FIGS. 10F-10H depict atrialanchoring arms 2440 of an exemplary prosthetic heart valve 6000. Atrialanchoring arms 2440 are situated within atrium 9010 and may engage theatrial side of native mitral valve 9030 to secure prosthetic heart valve6000 within the mitral valve; accordingly, atrial anchoring arms 2440may be considered atrial tissue anchors in some embodiments.

In some embodiments, the atrial tissue anchors may be configured tominimize or prevent migration of the prosthetic valve, including in aventricular direction (that is, towards the ventricle), after theprosthetic valve is implanted. This may be due, at least in part, to theengagement of the atrial tissue anchors with native heart tissue (e.g.,the atrial side of the native mitral valve) and the inability of theatrial tissue anchors to pass through the heart valve orifice after theprosthetic valve is implanted. For example, the atrial tissue anchorsmay have sufficient length such that they may be configured to have agreater radius than the native heart valve. Additionally, oralternatively, the atrial tissue anchors may be configured to grasp orclamp tissue of the native heart valve to further anchor the prostheticvalve in place. For example, in the embodiment of FIGS. 10G and 10H,atrial anchoring arms 2440 (i.e., the exemplary atrial tissue anchors)may clamp tissue by exerting a ventricularly-directed force (that is, aforce directed towards ventricle 9020) on the tissue, thus creating asandwiching effect in coordination with ventricular anchoring legs 2240which may firmly anchor prosthetic heart valve 6000 within the mitralvalve.

The prosthetic valve may include two atrial tissue anchors, three atrialtissue anchors, four atrial tissue anchors, five atrial tissue anchors,six atrial tissue anchors, seven atrial tissue anchors, eight atrialtissue anchors, nine atrial tissue anchors, ten atrial tissue anchors,eleven atrial tissue anchors, twelve atrial tissue anchors, thirteenatrial tissue anchors, fourteen atrial tissue anchors, fifteen atrialtissue anchors, sixteen atrial tissue anchors, seventeen atrial tissueanchors, eighteen atrial tissue anchors, nineteen atrial tissue anchors,twenty atrial tissue anchors, or any other suitable number of atrialtissue anchors. For example, exemplary prosthetic valve 6000 depicted inFIG. 2B may include twelve atrial anchoring arms 2440 (i.e., exemplaryatrial tissue anchors).

In some embodiments, the annular valve body may include one or moreframes. In some embodiments, the annular valve body may include an outerframe and an inner frame situated at least partially within the outerframe. In some embodiments, one or both of the inner frame and the outerframe may be annular, and the inner frame may be positioned within anopening of the outer frame. For example, FIG. 2A depicts an exemplaryprosthetic valve frame 2000 having an outer frame 2200 and an innerframe 2400. In some alternative embodiments, the inner frame may besituated entirely within the outer frame. One or both of the inner frameand the outer frame may be configured to radially expand between aradially-contracted configuration (e.g., a crimped state) and aradially-expanded configuration. In some embodiments, the inner framemay be configured to receive or otherwise support a flow control device,such as one or more leaflets, for regulating flow of blood or otherbodily fluids through the prosthetic valve.

In some embodiments, the tissue anchors configured to engage ventriculartissue may be configured to extend from the annular outer frame.Additionally, or alternatively, the exemplary atrial tissue anchors maybe configured to extend from the inner frame. For example, FIG. 3Adepicts atrial anchoring arms 2440 (i.e., the exemplary atrial tissueanchors) extending from inner frame 2400, and FIG. 3C depictsventricular anchoring legs 2240 (i.e., the exemplary ventricular tissueanchors) extending from outer frame 2200. In some embodiments, theatrial tissue anchors and the ventricular tissue anchors may bephysically connected to the inner frame and annular outer frame,respectively, such as by welding or adhesive. In some alternativeembodiments, the atrial tissue anchors and the ventricular tissueanchors may be integrally formed with the inner frame and annular outerframe, respectively.

In some embodiments, the locations of connection between the atrialtissue anchors and the inner frame may be spaced at a regular intervalabout a circumference of the inner frame. For example, in FIG. 2A, theatrial anchoring arms 2440 (i.e., the exemplary atrial tissue anchors)may extend from inner frame 2400 at arm attachment junctions 3202. Armattachment junctions 3202 may be spaced at a regular interval about thecircumference of inner frame 2400. Additionally, or alternatively, thelocations of connection between the atrial tissue anchors and the innerframe may be arranged along a plane perpendicular to the longitudinalaxis of the prosthetic valve. For example, in FIG. 2A, the armattachment junctions 3202 may be arranged along a plane perpendicular tolongitudinal axis 2800. That is, the arm attachment junctions 3202 maybe situated at the same axial position along longitudinal axis 2800.

In some embodiments, the protective sleeve may be configured to contacta radially inner surface of the inner frame and a radially outer surfaceof the annular outer frame. For example, the ventricular end of theinner frame may be situated within the ventricular end of the annularouter frame, such that both the inner frame and outer frame form theoutlet opening rim. The protective sleeve may wrap around the outletopening rim, thus extending from the radially inner surface of the innerframe to the radially outer surface of the annular outer frame. Forexample, FIG. 6A illustrates protective sleeve 6102 extending around andcontacting exemplary outer frame 2200, and FIG. 6B illustratesprotective sleeve 6102 extending around and contacting exemplary innerframe 2400.

The foregoing description has been presented for purposes ofillustration. It is not exhaustive and is not limited to precise formsor embodiments disclosed. Modifications and adaptations of theembodiments will be apparent from consideration of the specification andpractice of the disclosed embodiments. For example, while certaincomponents have been described as being coupled to one another, suchcomponents may be integrated with one another or distributed in anysuitable fashion.

Moreover, while illustrative embodiments have been described herein, thescope includes any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations based on the presentdisclosure. The elements in the claims are to be interpreted broadlybased on the language employed in the claims and not limited to examplesdescribed in the present specification or during the prosecution of theapplication, which examples are to be construed as nonexclusive.Further, the steps of the disclosed methods can be modified in anymanner, including reordering steps and/or inserting or deleting steps.

The features and advantages of the disclosure are apparent from thedetailed specification, and thus, it is intended that the appendedclaims cover all systems and methods falling within the true spirit andscope of the disclosure. As used herein, the indefinite articles “a” and“an” mean “one or more.” Similarly, the use of a plural term does notnecessarily denote a plurality unless it is unambiguous in the givencontext. Words such as “and” or “or” mean “and/or” unless specificallydirected otherwise. Further, since numerous modifications and variationswill readily occur from studying the present disclosure, it is notdesired to limit the disclosure to the exact construction and operationillustrated and described, and, accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thedisclosure.

Other embodiments will be apparent from consideration of thespecification and practice of the embodiments disclosed herein. It isintended that the specification and examples be considered as exampleonly, with a true scope and spirit of the disclosed embodiments beingindicated by the following claims.

What is claimed is:
 1. An expandable prosthetic valve for implantationwithin a native heart valve, the prosthetic valve comprising: anexpandable annular valve body having: an atrial inlet opening situatedat an upstream end of the annular valve body, a ventricular outletopening situated at a downstream end of the annular valve body, and aplurality of tissue anchors extending from the annular valve body; and aflexible annular protective sleeve extending continuously over a rim ofthe valve body outlet opening and affixed to the valve body outletopening, wherein the protective sleeve is situated over a skirt layercovering at least a portion of an outer surface of the annular valvebody, the skirt layer extending to the downstream end of the annularvalve body.
 2. The prosthetic valve of claim 1, wherein the protectivesleeve is constructed of a polymer.
 3. The prosthetic valve of claim 1,wherein the protective sleeve is constructed of PTFE.
 4. The prostheticvalve of claim 1, wherein stitching is passed around the protectivesleeve to secure it relative to the rim of the valve body outletopening.
 5. The prosthetic valve of claim 4, wherein the stitching doesnot pass through the protective sleeve.
 6. The prosthetic valve of claim4, wherein the stitching passes between an area within the annular valvebody and an area external to the annular valve body.
 7. The prostheticvalve of claim 1, wherein the protective sleeve wraps around the rim ofthe valve body outlet opening.
 8. The prosthetic valve of claim 1,wherein the protective sleeve extends over at least a portion of aradially inner surface of the annular valve body and at least a portionof the outer surface of the annular valve body.
 9. The prosthetic valveof claim 1, wherein the protective sleeve is configured to protectchordae tendineae from damage by the prosthetic valve.
 10. Theprosthetic valve of claim 1, wherein a thickness of the protectivesleeve is larger than a thickness of the skirt layer.
 11. The prostheticvalve of claim 1, wherein the protective sleeve does not contact theplurality of tissue anchors.
 12. The prosthetic valve of claim 1,wherein radial expansion and contraction of the annular valve body issubstantially unimpeded by the protective sleeve.
 13. The prostheticvalve of claim 1, wherein movement of the plurality of tissue anchorsbetween a radially-contracted configuration and a radially-expandedconfiguration is substantially unimpeded by the protective sleeve. 14.The prosthetic valve of claim 1, further comprising: at least one postsecured to the annular valve body and configured to engage a deliverytool, wherein the at least one post extends in a ventricular directionbeyond the protective sleeve.
 15. The prosthetic valve of claim 14,wherein the at least one post is situated at a radially inward positionrelative to the protective sleeve.
 16. The prosthetic valve of claim 1,further comprising: a plurality of leaflets situated within the annularvalve body, wherein a point of connection between the leaflets and theannular valve body is: aligned in a common lateral plane with theprotective sleeve, or situated in an atrial direction relative to theprotective sleeve.
 17. The prosthetic valve of claim 1, wherein thetissue anchors are configured to engage ventricular tissue of a nativeheart valve, and wherein the prosthetic valve further comprises aplurality of atrial tissue anchors configured to engage atrial tissue ofthe native heart valve.
 18. The prosthetic valve of claim 17, whereinthe annular valve body includes an annular outer frame and an innerframe situated at least partially within the annular outer frame,wherein the tissue anchors configured to engage ventricular tissueextend from the annular outer frame, and wherein the atrial tissueanchors extend from the inner frame.
 19. The prosthetic valve of claim18, wherein the protective sleeve covers at least a portion of aradially inner surface of the inner frame and at least a portion of aradially outer surface of the annular outer frame.
 20. The prostheticvalve of claim 1, wherein the protective sleeve is secured to the skirtlayer via stitching.